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Not recruiting
Early Phase 1

Ketamine

Sponsor:

Alta Bates Summit Medical Center

Code:

NCT06064162

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ketamine

Study Details

Brief summary:

The purpose of this study is to see whether using ketamine to increase glutamate in the prefrontal cortex can reduce Multiple Sclerosis (MS) related fatigue. The investigator proposes a prospective, crossover, randomized, placebo-controlled study to assess the efficacy and safety of low, single dose Ketamine, to assess its efficacy and safety in patients with MS-related fatigue.

Conditions

Multiple Sclerosis

Study ID

NCT06064162

Start date

Dec 5, 2023

Status verified date

Jun, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Female and Male patients with any form of CDMS ages 18-65 inclusive
2. Report fatigue which is interfering with QOL
3. Able and willing to sign informed consent
4. Stable on DMT for at least 3 months prior to baseline visit
5. Not experiencing an MS relapse within 90 days prior to baseline visit.
6. Must agree to practice an acceptable method of contraception
7. Experiencing significant fatigue due to MS (MFIS of ≥10)

Exclusion Criteria:

1. Allergy to Ketamine
2. Taking medications which may interact with ketamine
3. Change in DMT within 3 months prior to baseline visit
4. MS relapse within 90 days of the baseline visit
5. Confirmed diagnosis of untreated Sleep Apnea
6. Confirmed diagnosis of periodic limb movement disorder
7. Serious infection in the 30 days prior to baseline visit.
8. Patients with significant comorbid conditions:

1. Untreated hypertension (SBP>160, DBP>100 at baseline)
2. Liver disease
3. Significant renal disease
4. History of cardiac arrhythmia
5. Any comorbidities which at the opinion of the investigators post undue risk
9. Current alcohol or drug abuse
10. Participation in another interventional clinical trial in the past 3 months.
11. Pregnant or lactating
12. Any condition which in the opinion of the investigators will cause safety concerns for the patient, or inability to comply with the protocol.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ketamine (active treatment)

dose of 0.5 mg/kg intravenously over 40 minutes on day 1

placebo comparator: Saline (placebo treatment)

Placebo (saline solution) over 40 minutes on day 1

Interventions

ketamine

60mg (.5mg/kg over 40 minutes intravenously)

Primary outcome measure

  • Improve Fatigue Scores [ Time Frame: 28 days post study drug infusion ]

Central Contacts and Locations

Locations

Alta Bates Summit Medical Center

Recruiting

Berkeley, California, United States, 94705

Contacts

More Information

Sponsor

Alta Bates Summit Medical Center

Last update posted

Jun 6, 2024

Last verified

Jun, 2024

Keywords

  • MS related Fatigue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Alta Bates Summit Medical Center on 2024-06-06.