GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis

NCT01128738 | Completed Phase 3 Results

• 1 other identifier: 114078
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 14

Brief Summary

The primary objective of this study is to demonstrate superiority of single treatment of GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal injections based on gravimetric assessment (measurement of spontaneous axillary sweat production) for axillary hyperhidrosis.

Conditions

Hyperhidrosis

Keywords

Neuromuscular Agents; Botulinum Toxin Type A; Sweating; Sweat Gland Disease; Axillary Hyperhidrosis; Skin Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase

  A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.

  Week 4

Secondary Outcomes (47)

• Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase

  Weeks 1, 8 ,12, 16, 20, and 24

• Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase

  Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24

• Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase

  Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24

• Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase

  Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

• Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase

  Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40

Study Arms (2)

GSK1358820

ACTIVE COMPARATOR

Onabotulinum toxin type A

Drug: GSK1358820

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

GSK1358820 DRUG

Onabotulinum toxin type A

GSK1358820

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<At start of the screening phase (Visit 1)\>
• At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
• Patients with primary axillary hyperhidrosis whose excessive sweating in each axillae interferes daily life activities and whose Hyperhidrosis Disease Severity Scale (HDSS) score is 3 or 4.
• Age of 20 to 75 years at the time of informed consent.
• Both genders are eligible to enrol in the study. For men, only those who can practice contraception during the study period are eligible. Women of childbearing potential may be enrolled only if they have negative pregnancy test both in the screening period and just before treatment. Women of childbearing potential must agree to use one or more of the following reliable contraceptive measures throughout the study period:
• \*: Abstinence, oral contraceptives, progesterone injection, levonorgestrel implant, estrogen ring, transdermal contraceptives, intrauterine device, vasectomized partner, and double-barrier contraception (condom or diaphragm with spermicidal jelly/film).
• QTc \<450 msec, or QTc \<480 msec in patients with bundle branch block. (QTc should be determined on one beat on echocardiogram (ECG) or determined by average on consecutive three beats.)
• Willing and able to provide written informed consent. \<At start of the treatment phase (Visit 2)\>
• At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.)
• Patients with primary axillary hyperhidrosis whose excessive sweating in each axillae interferes daily life activities and whose HDSS score is 3 or 4.
• Asparate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 2 x upper limit of normal (ULN), Alkaline phosphatase (ALP) and bilirubin \<= 1.5 x ULN at Visit 1 (Free bilirubin \>= 1.5 × ULN will not directly lead to study discontinuation if bilirubin fraction test result of direct bilirubin \<35% is available.)

You may not qualify if:

• \<At start of the screening phase (Visit 1)\>
• Any systemic neuromuscular junction disorder (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis).
• Previous botulinum toxin treatment.
• Expected use of botulinum toxin for the treatment of any other disease during the study period.
• Known allergy to any of the components in the investigational product or iodine.
• Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria.
• Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.
• Concurrent use of antibiotics that may interfere with neuromuscular junction function, for example, aminoglycoside antibiotics (e.g., gentamicin sulfate, fradiomycin sulfate), polypeptide antibiotics (e.g., polymixin B sulfate), tetracycline antibiotics, and lincomycin antibiotics, except for those contained in topical antimicrobials.
• Concurrent use of muscle relaxants (e.g., tubocurarin chloride hydrochloride hydrate, dantrolene sodium hydrate) or drugs that may have a muscle relaxant action (e.g. spectinomycin hydrochloride hydrate, antispasmogenics including baclofen, benzodiazepines and benzodiazepine-like drugs, benzamides).
• Chronic respiratory disorder.
• Serious muscle weakness or atrophy.
• Angle closure glaucoma or its precipitation (narrow angle).
• Dermal disorder including infection at anticipated injection sites in either axilla.
• Subject has serious physical symptom(s) (i.e., cardiac / hepatic / renal / hematopoietic disorder). The index of seriousness is Grade 3 of "criteria for classification of seriousness of adverse drug reactions to pharmaceutical products, etc. : Appendix 3" (Pharmaceutical Affairs bureau / Pharmaceutical and Chemical Safety Division (PAB / PSD) Notification No.80 in 1992).
• Anticipated need for surgery or hospitalization during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (14)

GSK Investigational Site

Aichi, 480-1195, Japan

Location

GSK Investigational Site

Kanagawa, 220-6208, Japan

Location

GSK Investigational Site

Miyagi, 983-0039, Japan

Location

GSK Investigational Site

Saitama, 330-0854, Japan

Location

GSK Investigational Site

Tokyo, 107-0052, Japan

Location

GSK Investigational Site

Tokyo, 113-8519, Japan

Location

GSK Investigational Site

Tokyo, 141-8625, Japan

Location

GSK Investigational Site

Tokyo, 158-0094, Japan

Location

GSK Investigational Site

Tokyo, 158-0097, Japan

Location

GSK Investigational Site

Tokyo, 165-0026, Japan

Location

GSK Investigational Site

Tokyo, 166-0003, Japan

Location

GSK Investigational Site

Tokyo, 174-0071, Japan

Location

GSK Investigational Site

Tokyo, 178-0063, Japan

Location

GSK Investigational Site

Tokyo, 182-0002, Japan

Location

MeSH Terms

Conditions

Hyperhidrosis; Sweat Gland Diseases; Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 24, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 8, 2015
• Results First Posted: April 25, 2012

Record last verified: 2015-05

Locations

JP (14)