Clinical trial NCT01359566 (phase 3, status: completed)
Conditions: multiple sclerosis
ICD codes: G35, C81.18
Drugs: arbaclofen placarbil 15 mg bid, placebo, arbaclofen placarbil 30 mg bid, arbaclofen placarbil 45 mg bid
SMILES: [H][C@@](CN)(CC(O)=O)C1=CC=C(Cl)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@](CN)(CC(O)=O)C1=CC=C(Cl)C=C1, [H][C@@](CN)(CC(O)=O)C1=CC=C(Cl)C=C1
Eligibility criteria:

        Inclusion Criteria:

          1. 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).

          2. Maximum Ashworth Score Scale score of ≥ 2 in at least one of the following muscle
             groups on either side of the body: hip abductors/adductors, knee flexors/extensors,
             ankle flexors/extensors.

          3. Expanded Disability Status Scale (EDSS) rating between 3.0-8.0 inclusive.

          4. 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.

          5. Spasticity Disability Rating of 2 or higher at Baseline.

          6. 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).

        Exclusion Criteria:

          1. Spasticity due to neurological disorder other than MS or other conditions that may
             confound the assessment of spasticity.

          2. Subject has clinically evident muscle contractures resulting in irreversible
             spasticity in lower extremities.

          3. 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

          4. Botulinum toxin injection within 6 months of Screening or has current residual
             associated side effects at Screening.

          5. Subjects receiving concomitant medication from more than one of the following three
             drug classes: (Antiepileptic drugs, Tricyclic anti-depressants and Opioids)

          6. 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.

          7. Evidence of unstable or severe systemic illness, including but not limited to:
             Cardiovascular disease (e.g., chronic ventricular arrhythmia, unstable angina or CHF),
             respiratory disease (e.g., sleep apnea, COPD requiring oxygen therapy or
             hospitalization in last year), endocrine disease, hepatic disease (e.g., chronic
             active hepatitis), renal disease, or immunodeficiency.