Trial record 2 of 4 for:
MS and arbaclofen
Arbaclofen Placarbil for the Treatment of Spasticity in Subjects With Multiple Sclerosis (MS)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: May 23, 2011
Last updated: April 18, 2013
Last verified: April 2013
This is an open-label, 26-week safety and efficacy study in subjects with spasticity due to MS who have completed the XP-B-089 Study, and also includes an addendum open-label, 36-week safety study in subjects with spasticity due to MS who have not participated in the XP-B-089 study to assess the long-term safety and efficacy of arbaclofen placarbil in subjects with spasticity due to MS.
Drug: arbaclofen placarbil
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open Label, 26-Week Study Assessing Arbaclofen Placarbil Safety and Efficacy in Subjects With Spasticity Associated With Multiple Sclerosis With an Addendum Open-Label, 36-Week Study Assessing Arbaclofen Placarbil Safety in Subjects With Spasticity Associated With Multiple Sclerosis
Primary Outcome Measures:
- Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, severe TEAEs, related TEAEs, TEAEs leading to early withdrawal, TEAEs during taper, and TEAEs due to abrupt discontinuation. [ Time Frame: 26 and 36 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in maximum Ashworth score through the end of treatment [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Experimental: 45 mg BID
Drug: arbaclofen placarbil
This is an open-label study during which all subjects will be initiated and maintained on 45 mg BID of arbaclofen placarbil therapy for 26 or 36 weeks
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Primary Study Inclusion:
- Subjects who have successfully completed study XP-B-089.
- If a subject is on disease modifying MS treatment, the dosage, frequency, and route of administration must have remained stable for the duration of study XP-B-089.
- Willing to continue to refrain from using for the duration of the study drugs for the treatment of spasticity or likely to affect spasticity including, but not limited to, baclofen, tizanidine, diazepam, clonazepam, metaxalone, dantrolene, cyclobenzaprine, carisoprodol, clonidine, vigabatrin, valproic acid, and cannabis (refer to Appendix 2, Prohibited Concomitant Medications).
Primary Study Exclusion:
- Scheduled elective surgery or other procedures requiring general anesthesia during the study.
- Subjects who, in the opinion of the Investigator, would be non-compliant with the study visit schedule, procedures, or medication administration.
- Subjects who have an unstable or clinically significant medical or psychiatric illness that, in the opinion of the Investigator, could confound the collection of meaningful safety data or pose a risk to the subject.
- Treatment with botulinum toxin products, phenol, or alcohol injections during or subsequent to the previous study XP-B-089, or plans to receive these treatments during the time period of study XP-B-091
Addendum Study Inclusion:
- Has multiple sclerosis (MS) based on Poser or McDonald Criteria (all subtypes of MS will be accepted, including relapsing remitting, primary or secondary progressive, if disease is stable per exclusion criteria).
- Expanded Disability Status Scale (EDSS) rating between 3.0-8.0 inclusive
- Spasticity Disability Rating of 2 or higher at Screening
- If a subject is on disease modifying MS treatment, the dosage, frequency, and route of administration must be stable for at least 30 days before screening and is expected to be stable throughout the study.
- Willing to discontinue and refrain from using for the duration of the study drugs for the treatment of spasticity or likely to affect spasticity (including, but not limited to, baclofen tizanidine, diazepam, clonazepam, metaxalone, dantrolene, cyclobenzaprine, carisoprodol, clonidine, vigabatrin, valproic acid and cannabis).
Addendum Study Exclusion:
- Spasticity due to neurological disorder other than MS or other conditions that may confound the assessment of spasticity.
- Subject has clinically evident muscle contractures resulting in irreversible spasticity in lower extremities.
- Subjects who have suffered an acute relapse of MS (as determined by the Investigator) within 90 days prior to Screening, or have had more than 1 relapse within the year prior to Screening.
- Subjects receiving concomitant medication from more than one of the following three drug classes: (Antiepileptic drugs, Tricyclic anti-depressants and Opioids)
At the start, subjects on the following medications, at doses above the specified limits, are excluded if they cannot maintain a level within these limits:
- Gabapentin ≤ 1800 mg per day or pregabalin ≤ 150 mg per day
- Amitriptyline ≤ 75 mg per day or nortriptyline ≤ 75 mg per day
- Opioids ≤ 30 mg morphine equivalents per day.
- Botulinum toxin, phenol, or alcohol injections within 6 months of screening.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360489
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 23, 2011
||April 18, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2013
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Signs and Symptoms
GABA-B Receptor Agonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Muscle Relaxants, Central
Peripheral Nervous System Agents
Central Nervous System Agents