A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

NCT00220337 | Completed Phase 3 Results

• 2 other identifiers: SP08302004-000960-28
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain. Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. The maximum dose will be 600mg/day. Subjects may participate in this trial until October 2007. This time may be extended to allow them to participate until lacosamide is commercially available. If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication, s/he enters a Titration Phase to determine the personal optimal dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter.

Conditions

Painful Diabetic Neuropathy

Keywords

Painful diabetic neuropathy; Lacosamide

Outcome Measures

Primary Outcomes (48)

• Percentage of Subjects With Adverse Events (AE) Reported Spontaneously by the Subject or Observed by the Investigator

  An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

  From Screening until Safety Follow up Visit (up to 140 weeks)

• Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Titration Period

  Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (\<=.85x Lower Limit Normal \[LLN\] or \>= 1.15x Upper Limit Normal \[ULN\] - Hemoglobin (\<=.85x LLN or \>=1.15x ULN) - White Blood Cell (WBC) Count (\<=3.0 or \>=16.0 G/l) - Basophils (\>=5.0%) - Eosinophils (\>=10%) - Monocytes (\>=20%) - Platelet Count (\<=100 or \>=600 G/l)

  During the titration period (up to Week 8)

• Percentage of Subjects With Marked Abnormalities in Hematology Parameters After Start of Treatment During the Maintenance Period

  Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (\<=.85x Lower Limit Normal \[LLN\] or \>= 1.15x Upper Limit Normal \[ULN\] - Hemoglobin (\<=.85x LLN or \>=1.15x ULN) - White Blood Cell (WBC) Count (\<=3.0 or \>=16.0 G/l) - Basophils (\>=5.0%) - Eosinophils (\>=10%) - Monocytes (\>=20%) - Platelet Count (\<=100 or \>=600 G/l)

  During the maintenance period (up to 136 weeks)

• Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Titration Period

  Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase (\[ALT\] 3x ULN) - Alanine aminotransferase (\[ALT\] 5x ULN) - Alanine aminotransferase \[(ALT\] 10x ULN) - Aspartate aminotransferase (\[AST\] 3x ULN) - Aspartate aminotransferase (\[AST\] 5x ULN) - Aspartate aminotransferase (\[AST\] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase (\[GGT\] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (\<26 g/l) - Blood Urea Nitrogen (\>=14.28 mmol/l) - Creatinine (\>=2.0 mg/dl) - Calcium (\<=7.6 or \>=11.0 mg/dl) - Chloride (\<=90 or \>=112 mmol/l) - Phosphorus (\<=2.0 or \>=6.0 mg/dl) - Potassium (\<=3.0 or \>=6.0 mmol/l) - Sodium (\<127 or \>151 mmol/l) - Glucose (\<50 or \>=200 mg/dl) - Total Cholesterol (\>6.5 mmol/l) - Uric Acid (\>565.06 umol/l)

  During the titration period (up to Week 8)

• Percentage of Subjects With Marked Abnormalities Clinical Chemistry Parameters After Start of Treatment During the Maintenance Period

  Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase (\[ALT\] 3x ULN) - Alanine aminotransferase (\[ALT\] 5x ULN) - Alanine aminotransferase \[(ALT\] 10x ULN) - Aspartate aminotransferase (\[AST\] 3x ULN) - Aspartate aminotransferase (\[AST\] 5x ULN) - Aspartate aminotransferase (\[AST\] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase (\[GGT\] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (\<26 g/l) - Blood Urea Nitrogen (\>=14.28 mmol/l) - Creatinine (\>=2.0 mg/dl) - Calcium (\<=7.6 or \>=11.0 mg/dl) - Chloride (\<=90 or \>=112 mmol/l) - Phosphorus (\<=2.0 or \>=6.0 mg/dl) - Potassium (\<=3.0 or \>=6.0 mmol/l) - Sodium (\<127 or \>151 mmol/l) - Glucose (\<50 or \>=200 mg/dl) - Total Cholesterol (\>6.5 mmol/l) - Uric Acid (\>565.06 umol/l)

  During the maintenance period (up to 136 weeks)

• Number of Subjects With Urine pH= 5.0 at Baseline, Categorized by Urine pH at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine pH= 6.0 at Baseline, Categorized by Urine pH at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine pH= 6.5 at Baseline, Categorized by Urine pH at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine pH= 7.0 at Baseline, Categorized by Urine pH at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine pH= 7.5 at Baseline, Categorized by Urine pH at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine pH= 8.0 at Baseline, Categorized by Urine pH at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine White Blood Cell Count 'Negative' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine White Blood Cell Count 'Trace' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine White Blood Cell Count 'Positive +' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine White Blood Cell Count 'Positive ++' at Baseline, Categorized by Urine White Blood Cell Count at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Nitrite Status 'Negative' at Baseline, Categorized by Urine Nitrite Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Nitrite Status 'Positive' at Baseline, Categorized by Urine Nitrite Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Urobilinogen Value 3 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit

  Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Urobilinogen Value 16 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit

  Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Urobilinogen Value 66 µmol/l at Baseline, Categorized by Urine Urobilinogen Value at Last Visit

  Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Protein Status 'Negative' at Baseline, Categorized by Urine Protein Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Protein Status 'Trace' at Baseline, Categorized by Urine Protein Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Protein Status 'Positive +' at Baseline, Categorized by Urine Protein Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Protein Status 'Positive ++' at Baseline, Categorized by Urine Protein Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Blood Status 'Negative' at Baseline, Categorized by Urine Blood Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Blood Status 'Trace (N)' at Baseline, Categorized by Urine Blood Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Blood Status 'Trace (H)' at Baseline, Categorized by Urine Blood Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Blood Status 'Positive +' at Baseline, Categorized by Urine Blood Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Blood Status 'Positive ++' at Baseline, Categorized by Urine Blood Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Ketone Status 'Negative' at Baseline, Categorized by Urine Ketone Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Ketone Status 'Trace' at Baseline, Categorized by Urine Ketone Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Ketone Status 'Small' at Baseline, Categorized by Urine Ketone Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Ketone Status 'Moderate' at Baseline, Categorized by Urine Ketone Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Bilirubin Status 'Negative' at Baseline, Categorized by Urine Bilirubin Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Bilirubin Status 'Positive +' at Baseline, Categorized by Urine Bilirubin Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Bilirubin Status 'Positive ++' at Baseline, Categorized by Urine Bilirubin Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Glucose Value 'Negative' at Baseline, Categorized by Urine Glucose Value at Last Visit

  Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Glucose Value 5.5 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit

  Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Glucose Value 14 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit

  Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Glucose Value 28 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit

  Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Glucose Value 55 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit

  Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Number of Subjects With Urine Glucose Value >=111 mmol/l at Baseline, Categorized by Urine Glucose Value at Last Visit

  Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

  Baseline, Last Visit (up to 140 weeks)

• Percentage of Subjects With Marked Abnormalities in Vital Signs After Start of Treatment

  Changes in vital signs examination findings is reported as percentage of subjects with marked abnormalities in - Systolic Blood Pressure (SBP) \>=180 mmHg and increase of \>=20 mmHg - Systolic Blood Pressure \>=90 mmHg and decrease of \>=20 mmHg - Diastolic Blood Pressure (DBP) \>=105 mmHg and increase of \>=15 mmHg - Diastolic Blood Pressure \>=50 mmHg and decrease of \>=15 mmHg - Pulse Rate (PR) \>=120 beats/min and increase of \>=15 beats/min - Pulse Rate \>=50 beats/min and decrease of \>=15 beats/min

  During study period (up to 140 weeks)

• Percentage of Subjects With Marked Abnormalities in Physical Examination Findings After Start of Treatment.

  Changes in physical examination findings is reported as percentage of subjects with marked abnormalities in following categories: - Ears, Eyes, Nose, Mouth, Throat - Cardiovascular - Peripheral vascular - Pulmonary - Musculoskeletal - Hepato- / Gastrointestinal - Renal / Genitourological - Neurological - Metabolic / Endocrine - Psychiatric - Hematological / Lymphatic Nodes - Dermatological - Other The percentages are based on the number of subjects with examinations done at each visit for each body system.

  Last Visit (up to 140 weeks)

• Percentage of Subjects With Marked Abnormalities in Neurological Examination Findings After Start of Treatment

  Changes in neurological examination findings is reported as percentage of subjects with marked abnormalities in following categories: - General - Cranial Nerves - Reflexes - Muscle Strength and Tone - Coordination and Cerebellar Function - Motor System - Sensation: Upper Extremities - Sensation: Lower Extremities The percentages are based on the number of subjects with examinations done at last visit for each category or parameter.

  Last Visit (up to 140 weeks)

• Percentage of Subjects With Abnormal Electrocardiogram (ECG) Findings

  Changes in 12-lead ECGs is reported as percentage of subjects with abnormal ECG findings categorized in 'Abnormal, possibly insignificant' and 'Abnormal, possibly significant' based on the alert criterion by the ECG vendor and not on the investigator's assessment.

  Last Visit (up to 140 weeks)

• Percentage of Subjects Who Withdrew Due to Adverse Events (AEs)

  An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

  During the study period (up to 140 weeks)

• Number of Subjects With Urine Protein Status 'Positive +++' at Baseline, Categorized by Urine Protein Status at Last Visit

  Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

  Last Visit (up to 140 weeks)

Secondary Outcomes (65)

• Change in Average Pain Interference With Sleep From the Baseline Week to the 7 Days Prior to Each Visit

  Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

• Change in Average Pain Interference With General Activity From the Baseline Week to the 7 Days Prior to Each Visit

  Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

• Change in Current Pain From Visit 2 (Baseline) to Each Subsequent Visit as Measured by a 100 mm Visual Analogue Scale (VAS)

  Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

• Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 4

  Visit 4

• Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 6

  Visit 6

Study Arms (1)

Lacosamide (LCM)

EXPERIMENTAL

Open label active treatment

Drug: Lacosamide

Interventions

Lacosamide DRUG

Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years

Also known as: SPM 927

Lacosamide (LCM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Painful diabetic neuropathy

You may not qualify if:

• no clinically relevant liver enzyme abnormalities and impaired renal function, no cardiac abnormalities, no pregnant or nursing females

Sponsors & Collaborators

• UCB Pharma: lead
• SCHWARZ BIOSCIENCES GmbH - Part of UCB Group: collaborator

Study Sites (1)

Unknown Facility

Monheim, Germany

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Lacosamide; 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  UCB (+1 844 599 2273)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 22, 2005
• Study Start: December 21, 2004
• Primary Completion: October 31, 2007
• Study Completion: October 31, 2007
• Last Updated: July 24, 2023
• Results First Posted: July 24, 2023

Record last verified: 2022-08

Locations

DE (1)