Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)

NCT04530955 | Unknown FDA Device

• 1 other identifier: AT-001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing the efficacy of Intracthecal Baclofen dose between the Prometra II and Medtronic SynchroMed II for patients with spasticity and with current a current SyncroMed II pump needing replacement.

Conditions

Injuries, Spinal Cord; CVA (Cerebrovascular Accident); Traumatic Brain Injury; MS (Multiple Sclerosis); Muscle Spasticity; Cerebral Palsy, Spastic

Keywords

Spasticity

Outcome Measures

Primary Outcomes (1)

• Comparison of spasticity control with Synchromed II versus Prometra II

  To evaluate that a Baclofen dose reduction delivered through a valve-gated intrathecal drug delivery system (Prometra II) provides spasticity control no less than the baseline dose delivered through a peristaltic intrathecal drug delivery system (SynchroMed II). NOTE: In this study, a modified Ashworth scores will be prospectively collected for valve-gated pumps and will be compared to retrospectively collected modified Ashworth scores prior to peristaltic pump explant.

  3 months

Secondary Outcomes (1)

• Comparison of patient report of spasm frequency with Synchromed II versus Prometra II

  3 months

Study Arms (2)

Control Arm

NO INTERVENTION

Patients randomized to the Control Arm that have been implanted with the valve-gated pump will be started on an equivalent dose (without change to the medication concentration) as prior to implant. If at any time during the patients' treatment it is determined by the investigator that the patients' treatment dose needs to be modified, the dose can be modified as clinically indicated. Multiple dosing decreases may be performed if the patient is clinically demonstrating a reduction in spasticity that is profound and negatively impacting function, or if the patient is demonstrating signs of baclofen overdose. The criteria for dosing decrease will be clinical discretion.

Study Arm

ACTIVE COMPARATOR

Patients randomized to the Study Arm will be started on a 20% dose reduction (without change to the medication concentration) through the newly implanted valve-gated pump. If at any time during the patients' treatment it is determined by the investigator that the patients' treatment dose needs to be increased or decreased, the dose can be increased/decreased as clinically indicated. If the dose increases with the valve-gated pump reach the patients' baseline dose and the patient's spasticity is worse than his or her spasticity at baseline, then the patient will be considered a primary endpoint failure. The criteria for dosing increase will be clinical discretion.

Device: Prometra II Programmable Pump - Flowonix Medical

Interventions

Prometra II Programmable Pump - Flowonix Medical DEVICE

The valve gated Prometra II Programmable Pump will be replacing the prior peristaltic Synchromed II pump and a 20% dose decrease will be performed at the time of the replacement.

Study Arm

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be male or female between the ages of 22 and 85 years
• Be capable of giving informed consent (or a legally authorized representative) and completing assessments required by the study
• Have modified Ashworth scores within 3 months prior to valve-gated pump implant
• Have an active existing SynchroMed II intrathecal drug delivery system needing replacement
• Existing ITB patient with spasticity of any origin.
• Have stable drug dosage for at least 3 months prior to valve-gated pump implant
• Be an appropriate candidate for surgery
• Be able to comply with required study visits and assessments including English proficiency

You may not qualify if:

• Be terminally ill and/or have a life expectancy of less than 12 months
• Be a pregnant/lactating woman.
• Have a systemic or local infection (contraindicated for pump implantation)
• Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments

Sponsors & Collaborators

• Culicchia Neurological Clinic: lead
• Flowonix Medical: collaborator

Study Sites (1)

Culicchia Neurological Clinic

Marrero, Louisiana, 70072, United States

RECRUITING

Related Publications (7)

• Ordia JI, Fischer E, Adamski E, Chagnon KG, Spatz EL. Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromodulation. 2002 Jan;5(1):16-24. doi: 10.1046/j.1525-1403.2002._2004.x.

  PMID: 22151777 BACKGROUND

• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

  PMID: 3809245 RESULT

• Lewis KS, Mueller WM. Intrathecal baclofen for severe spasticity secondary to spinal cord injury. Ann Pharmacother. 1993 Jun;27(6):767-74. doi: 10.1177/106002809302700618.

  PMID: 8329801 RESULT

• Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006 Nov;87(11):1509-15. doi: 10.1016/j.apmr.2006.08.323.

  PMID: 17084128 RESULT

• Saulino M, Ivanhoe CB, McGuire JR, Ridley B, Shilt JS, Boster AL. Best Practices for Intrathecal Baclofen Therapy: Patient Selection. Neuromodulation. 2016 Aug;19(6):607-15. doi: 10.1111/ner.12447. Epub 2016 Jul 19.

  PMID: 27434197 RESULT

• Middel B, Kuipers-Upmeijer H, Bouma J, Staal M, Oenema D, Postma T, Terpstra S, Stewart R. Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity. J Neurol Neurosurg Psychiatry. 1997 Aug;63(2):204-9. doi: 10.1136/jnnp.63.2.204.

  PMID: 9285459 RESULT

• Albright AL, Gilmartin R, Swift D, Krach LE, Ivanhoe CB, McLaughlin JF. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003 Feb;98(2):291-5. doi: 10.3171/jns.2003.98.2.0291.

  PMID: 12593613 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke; Brain Injuries, Traumatic; Multiple Sclerosis; Muscle Spasticity; Cerebral Palsy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic

Study Officials

• Andrea Toomer, MD

  Culicchia Neurological Clinic Partner

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassi Bodenheimer, RN

CONTACT

504-340-6976; cbodenheimer@culicchianeuro.com

Janet Smith

CONTACT

832-612-6326; busyproconsulting@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study will employ a single-blinded approach in which study participants will not be notified of pump dosing changes. After valve-gated pump implant and dose reduction, the appropriate spasticity therapy will be provided to adequately address spasticity management in the opinion of the study investigator using standard of care processes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor/ Principal Investigator/ MD

Model Details: Randomized, open label, single-blind, multi-center, post-market study

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 28, 2020
• Study Start: September 24, 2020
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: September 28, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)